DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 5-10, 12-15, 17, 19, 22, 24, 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Astarci et al. (US 20150088246 A1).
Regarding claim 1, Astarci discloses a rotational atherectomy device (Fig. 8) for cutting or abrading tissue, the atherectomy device comprising: a rotatable inner shaft 52 having a longitudinal axis (i.e., as shown in Figs. 8-10); a plurality of blades 50 (para. [0097]) connected to the distal end of the rotatable inner shaft (Figs. 8-10) through a spring mechanism which biases the plurality of blades radially outward (para. [0097]); and an outer shaft 40 disposed over the rotatable inner shaft (Figs. 8-10), wherein the rotatable inner shaft is longitudinally moveable with respect to the outer shaft (Figs. 8-10), and wherein distal movement of the inner shaft with respect to the outer shaft moves the plurality of blades from a radially contracted configuration (i.e., as shown in Fig. 10) to a radially expanded configuration (i.e., as shown in Fig. 8).
Regarding claim 5, Astarci discloses the rotational atherectomy device of claim 1. Astarci also discloses wherein the plurality of blades comprises 2 to 10 blades (i.e., plurality includes at least two).
Regarding claim 6, Astarci discloses the rotational atherectomy device of claim 1. Astarci also discloses wherein at least one of the plurality of blades comprises a cutting edge (para. [0097]).
Regarding claim 7, Astarci discloses the rotational atherectomy device of claim 6. Astarci also discloses wherein the cutting edge is positioned radially inwardly offset from a radial outermost point of the blade (para. [0097] i.e., at least by way of their conical shape).
Regarding claim 8, Astarci discloses the rotational atherectomy device of claim 6. Astarci also discloses wherein the cutting edge is disposed at a circumferential edge of the blade (para. [0097]).
Regarding claim 9, Astarci discloses the rotational atherectomy device of claim 1. Astarci also discloses wherein at least one of the plurality of blades has a claw-shaped axial cross section (i.e., at least by the conical shape as disclosed in para. [0097]).
Regarding claim 10, Astarci discloses the rotational atherectomy device of claim 1. Astarci also discloses wherein at least one of the plurality of blades comprises an abrasive surface disposed on a radial outer surface of the blade (para. [0084] discloses that cutting edges may include an abrasive or cutting material).
Regarding claim 12, Astarci discloses the rotational atherectomy device of claim 1. Astarci also discloses wherein the radial outer surface of at least one of the plurality of blades has a curved convex shape (para. [0097]).
Regarding claim 13, Astarci discloses the rotational atherectomy device of claim 1. Astarci also discloses wherein the plurality of blades are substantially straight along a longitudinal direction (i.e., at least in the closed collapsed position (see also para. [0097]).
Regarding claim 14, Astarci discloses the rotational atherectomy device of claim 1. Astarci also discloses wherein the outer shaft is in contact with at least one of the plurality of blades (para. [0098]).
Regarding claim 15, Astarci discloses the rotational atherectomy device of claim 1. Astarci also discloses wherein the outer shaft covers the plurality of blades in the radially contracted configuration (para. [0098]) and the amount of distal movement of the rotatable inner shaft relative to the outer shaft determines the amount of radial expansion of the blades (para. [0098]).
Regarding claim 17, Astarci discloses the rotational atherectomy device of claim 1. Astarci also discloses wherein the rotatable inner shaft and/or the outer shaft are flexible (paras. [0108], [0156]).
Regarding claim 19, Astarci discloses the rotational atherectomy device of claim 1. Astarci also discloses further comprising a control unit connected at the proximal end of the rotatable inner shaft and the outer shaft, wherein the control unit comprises a rotational motor for providing rotation to the rotatable inner shaft and is operable to control a speed of the rotational motor (para. [0113]).
Regarding claim 22, Astarci discloses the rotational atherectomy device of claim 19. Astarci also discloses wherein the control unit comprises an expansion control mechanism for moving the rotatable inner shaft longitudinally with respect to the outer shaft to thereby move the plurality of blades between the radially contracted configuration and the radially expanded configuration (para. [0098]).
Regarding claim 24, Astarci discloses the rotational atherectomy device of claim 1. Astarci also discloses wherein the rotatable inner shaft further comprises a guidewire lumen for accommodating a guidewire (para. [0107]).
Regarding claim 25, Astarci discloses a method of cutting or abrading tissue using a rotatable atherectomy device comprising a rotatable inner shaft 52 (para. [0038]), a plurality of blades connected to the distal end of the rotatable inner shaft through a spring mechanism which biases the plurality of blades radially outward (para. [0097]), and an outer shaft 40 disposed over the rotatable inner shaft; the method comprising: introducing the atherectomy device into a blood vessel (para. [0086]); advancing the atherectomy device to a position in the blood vessel where tissue is to be cut or abraded (para. [0038]); radially expanding the blades to the diameter of the vessel by distally advancing the inner shaft (para. [0093]); rotating the inner shaft to cut or abrade the tissue (para. [0093]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Astarci.
Regarding claim 2, Astarci discloses the rotational atherectomy device of claim 1. Astarci doesn’t directly disclose wherein the spring mechanism comprises a leaf spring or a torsion spring.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, as a matter of being obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of the spring mechanism comprises a leaf spring or a torsion spring, since Astarci discloses using a spring (para. [0097]) and there are limited types of springs to use that would be capable for use in the device. Since there are limited amount of options apparent to one of ordinary skill in the art, and there being no undue experimentation, there is a reasonable expectation of success at arriving at the spring mechanism comprises a leaf spring or a torsion spring.
Claims 3-4 rejected under 35 U.S.C. 103 as being unpatentable over Astarci in view of Spencer et al. (US 20130096589 A1).
Regarding claims 3 and 4, Astarci discloses the rotational atherectomy device of claim 1. Astarci doesn’t directly disclose wherein the outer shaft is rotatable, and wherein the rotatable outer shaft is configured to rotate together with the rotatable inner shaft.
In the same field of endeavor of atherectomy catheters and non-contact actuation mechanisms for catheters, Spencer discloses a similar atherectomy device 1400 to Astarci (see Figs. 17A-17B) and includes rotating the outer shaft (para. [0090]), and wherein the rotatable outer shaft is configured to rotate together with the rotatable inner shaft (para. [0090]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Astarci to have the outer shaft be rotatable together with the inner shaft for purposes of steering the device to the desired location (para. [0090]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Astarci in view of Malekmehr (US 20190038874 A1).
Regarding claim 23, Astarci discloses the rotational atherectomy device of claim 22. Astarci doesn’t directly disclose wherein the expansion control mechanism comprises a rack and pinion.
In the same field of endeavor, namely guidewires (i.e, and atherectomy devices as disclosed in para. [0106]), Malekmehr discloses a control mechanism 200 including a rack 201 and pinion 203 and a motor 205 coupled to the pinion 203.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention using known techniques in the art (i.e., using rack and pinion to actuate the tool) for the purpose of causing the shaft to rotate and/or deflect (i.e, see para. [0106]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
